FDA 483 - Qualgen LLC - June 15, 2021

This FDA Form 483 details observations from an inspection of Qualgen LLC, an outsourcing facility located at 14844 Bristol Park Blvd., Edmond, OK 73013. The inspection was conducted from April 29, 2021, to June 15, 2021. Shaun P. Riney is the CEO and Managing Partner.

The inspection revealed 15 observations indicating deficiencies in quality control, sterile manufacturing procedures, equipment maintenance, facility design, and labeling.

Key observations include: 1. **Inadequate Quality Control Unit:** The firm failed to establish an adequate quality control unit with proper authority and written procedures. Specifically, Testosterone Cypionate Injection 200mg/mL was distributed before antimicrobial effectiveness test results were received, and distribution continued even after a potential failure was indicated. There is no written procedure for new drug product release, and changes were made without documented Quality Control Unit review and approval. 2. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products are not established or followed. This includes a lack of written procedures for the (b)(4) test on Testosterone Cypionate Injection, and undefined procedures for handling fogging goggles in cleanrooms, leading to technicians touching faces with gloves and re-entering cleanrooms without proper sanitization. 3. **Lack of Pyrogen Removal Procedures:** No written methods exist for cleaning or processing to remove py